FDA Inspection
Pinnacle Fertility Labs New YorkPinnacle Fertility Labs New York – FDA Inspection, Dec 14, 2023
Record Details
This FDA Inspection record concerns Pinnacle Fertility Labs New York, with an inspection on December 14, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d85dc753-dfd9-47b6-9c81-4806a4f254c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225050
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Pinnacle Fertility Labs New York
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Pinnacle Fertility Labs New York
- FDA Inspection 1330492 - 2026-08-06
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